As a Diagnostic Consumables Engineer, you will be a part of a fast-pace, multi-disciplines, and creative team that drive new product development and implement continuous improvements to new and existing processes. The ability to develop products, trouble-shoot, define root cause, provide resolution, and implement the necessary changes efficiently in an FDA regulated environment is critical. The ability to identify problem and create a solution through research and solid technical principles/disciplines is necessary.
In support of New Product Introduction (NPI) efforts, work with design engineers to optimize design drawings and supplier manufacturing processes so that high quality parts are consistently delivered.
- Create and develop new invasive and noninvasive medical device product(s) from initial design to market and manufacturing release.
- Hands on experience with validations, design for manufacture (DFM), material selection, and process development.
- Conduct feasibility studies of the design to determine ability to function as intended.
- Coordinate and drive new and existing consumable part and process qualifications from inception through completion in accordance with FDA and ISO guidelines.
- Maintain detailed documentation throughout all phases of development through manufacturing.
- Develop and document business practices, processes, procedures, and work instructions
- Determine and execute the most appropriate testing to address process and system level performance issues involving cartridge consumables.
- Lead technical aspects of Problem Solving, Failure Analysis, and Corrective and Preventative Actions with suppliers.
- Promote a culture of structured problem solving.
- Assist suppliers in developing final test requirements to ensure products meet specifications.
- Bachelor's degree in Engineering plus 5 years of related work experience with a good understanding of specified functional area, or Master's degree in engineering with 1-2 years of related work experience, or an equivalent combination of education and work experience.
- Experience with manufacturing processes, including machining, molding, ultrasonic welding.
- Experience with GDT (Geometric Dimensioning and Tolerancing), quality measurement technique and use of SolidWorks.
- Solid mathematical skills with basic statistics knowledge.
- Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
- May lead a project team of moderate scope. Provide guidance to less experienced staff.
- Work under general supervision. Follow established procedures. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.
- Working knowledge of design of experiments (DOE) and interpretation of test results
- Excellent communication skills. Must be able to communicate verbally in an efficient and effective and be proficient manner.
- Knowledge of the ISO 9001, EN 13485, EN ISO 14971 , 21CFR 820 and ANSI-Y14.5 standards.